BACKGROUND: Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear .
METHODS: The Passive Immunity Trial for Our Nation (PassITON) is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the USA to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma as a treatment for adults hospitalized with symptomatic disease . Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days are eligible . Enrolled patients are randomized in a 1:1 ratio to 1 unit (200-399 mL) of COVID-19 convalescent plasma that has demonstrated neutralizing function using a SARS-CoV-2 chimeric virus neutralization assay . Study treatments are administered in a blinded fashion and patients are followed for 28 days . The primary outcome is clinical status 14 days after study treatment as measured on a 7-category ordinal scale assessing mortality, respiratory support, and return to normal activities of daily living . Key secondary outcomes include mortality and oxygen-free days . The trial is projected to enroll 1000 patients and is designed to detect an odds ratio ≤ 0.73 for the primary outcome .
DISCUSSION: This trial will provide the most robust data available to date on the efficacy of COVID-19 convalescent plasma for the treatment of adults hospitalized with acute moderate to severe COVID-19. These data will be useful to guide the treatment of COVID-19 patients in the current pandemic and for informing decisions about whether developing a standardized infrastructure for collecting and disseminating convalescent plasma to prepare for future viral pandemics is indicated .
TRIAL REGISTRATION: ClinicalTrials.gov NCT04362176 . Registered on 24 April 2020.
MeSH: COVID-19, diagnosis, immunology, therapy, virology, Hospitalization, Host-Pathogen Interactions, Humans, Immunization, Passive, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, SARS-CoV-2, immunology, pathogenicity, Time Factors, Treatment Outcome, United States
Index: COVID-19, Clinical trials, Neutralizing antibodies, Passive immunity, Randomized controlled trial, SARS-CoV-2: convalescent plasma